Role of epidemiology in risk assessment: a case study of five ortho-phthalates

Abstract Background The association between environmental chemical exposures and chronic diseases is of increasing concern. Chemical risk assessment relies heavily on pre-market toxicity testing to identify safe levels of exposure, often known as reference doses (RfD), expected to be protective of h...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Maricel V. Maffini, Birgit Geueke, Ksenia Groh, Bethanie Carney Almroth, Jane Muncke
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Phthalates Reference dose Risk assessment Epidemiology Human health Industrial medicine. Industrial hygiene RC963-969 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/09fff206d0574e8182513e32fe14854d
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:09fff206d0574e8182513e32fe14854d
record_format	dspace
spelling	oai:doaj.org-article:09fff206d0574e8182513e32fe14854d2021-11-21T12:33:08ZRole of epidemiology in risk assessment: a case study of five ortho-phthalates10.1186/s12940-021-00799-81476-069Xhttps://doaj.org/article/09fff206d0574e8182513e32fe14854d2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12940-021-00799-8https://doaj.org/toc/1476-069XAbstract Background The association between environmental chemical exposures and chronic diseases is of increasing concern. Chemical risk assessment relies heavily on pre-market toxicity testing to identify safe levels of exposure, often known as reference doses (RfD), expected to be protective of human health. Although some RfDs have been reassessed in light of new hazard information, it is not a common practice. Continuous surveillance of animal and human data, both in terms of exposures and associated health outcomes, could provide valuable information to risk assessors and regulators. Using ortho-phthalates as case study, we asked whether RfDs deduced from male reproductive toxicity studies and set by traditional regulatory toxicology approaches sufficiently protect the population for other health outcomes. Methods We searched for epidemiological studies on benzyl butyl phthalate (BBP), diisobutyl phthalate (DIBP), dibutyl phthalate (DBP), dicyclohexyl phthalate (DCHP), and bis(2-ethylhexyl) phthalate (DEHP). Data were extracted from studies where any of the five chemicals or their metabolites were measured and showed a statistically significant association with a health outcome; 38 studies met the criteria. We estimated intake for each phthalate from urinary metabolite concentration and compared estimated intake ranges associated with health endpoints to each phthalate’s RfD. Result For DBP, DIBP, and BBP, the estimated intake ranges significantly associated with health endpoints were all below their individual RfDs. For DEHP, the intake range included associations at levels both below and above its RfD. For DCHP, no relevant studies could be identified. The significantly affected endpoints revealed by our analysis include metabolic, neurodevelopmental and behavioral disorders, obesity, and changes in hormone levels. Most of these conditions are not routinely evaluated in animal testing employed in regulatory toxicology. Conclusion We conclude that for DBP, DIBP, BBP, and DEHP current RfDs estimated based on male reproductive toxicity may not be sufficiently protective of other health effects. Thus, a new approach is needed where post-market exposures, epidemiological and clinical data are systematically reviewed to ensure adequate health protection.Maricel V. MaffiniBirgit GeuekeKsenia GrohBethanie Carney AlmrothJane MunckeBMCarticlePhthalatesReference doseRisk assessmentEpidemiologyHuman healthIndustrial medicine. Industrial hygieneRC963-969Public aspects of medicineRA1-1270ENEnvironmental Health, Vol 20, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Phthalates Reference dose Risk assessment Epidemiology Human health Industrial medicine. Industrial hygiene RC963-969 Public aspects of medicine RA1-1270
spellingShingle	Phthalates Reference dose Risk assessment Epidemiology Human health Industrial medicine. Industrial hygiene RC963-969 Public aspects of medicine RA1-1270 Maricel V. Maffini Birgit Geueke Ksenia Groh Bethanie Carney Almroth Jane Muncke Role of epidemiology in risk assessment: a case study of five ortho-phthalates
description	Abstract Background The association between environmental chemical exposures and chronic diseases is of increasing concern. Chemical risk assessment relies heavily on pre-market toxicity testing to identify safe levels of exposure, often known as reference doses (RfD), expected to be protective of human health. Although some RfDs have been reassessed in light of new hazard information, it is not a common practice. Continuous surveillance of animal and human data, both in terms of exposures and associated health outcomes, could provide valuable information to risk assessors and regulators. Using ortho-phthalates as case study, we asked whether RfDs deduced from male reproductive toxicity studies and set by traditional regulatory toxicology approaches sufficiently protect the population for other health outcomes. Methods We searched for epidemiological studies on benzyl butyl phthalate (BBP), diisobutyl phthalate (DIBP), dibutyl phthalate (DBP), dicyclohexyl phthalate (DCHP), and bis(2-ethylhexyl) phthalate (DEHP). Data were extracted from studies where any of the five chemicals or their metabolites were measured and showed a statistically significant association with a health outcome; 38 studies met the criteria. We estimated intake for each phthalate from urinary metabolite concentration and compared estimated intake ranges associated with health endpoints to each phthalate’s RfD. Result For DBP, DIBP, and BBP, the estimated intake ranges significantly associated with health endpoints were all below their individual RfDs. For DEHP, the intake range included associations at levels both below and above its RfD. For DCHP, no relevant studies could be identified. The significantly affected endpoints revealed by our analysis include metabolic, neurodevelopmental and behavioral disorders, obesity, and changes in hormone levels. Most of these conditions are not routinely evaluated in animal testing employed in regulatory toxicology. Conclusion We conclude that for DBP, DIBP, BBP, and DEHP current RfDs estimated based on male reproductive toxicity may not be sufficiently protective of other health effects. Thus, a new approach is needed where post-market exposures, epidemiological and clinical data are systematically reviewed to ensure adequate health protection.
format	article
author	Maricel V. Maffini Birgit Geueke Ksenia Groh Bethanie Carney Almroth Jane Muncke
author_facet	Maricel V. Maffini Birgit Geueke Ksenia Groh Bethanie Carney Almroth Jane Muncke
author_sort	Maricel V. Maffini
title	Role of epidemiology in risk assessment: a case study of five ortho-phthalates
title_short	Role of epidemiology in risk assessment: a case study of five ortho-phthalates
title_full	Role of epidemiology in risk assessment: a case study of five ortho-phthalates
title_fullStr	Role of epidemiology in risk assessment: a case study of five ortho-phthalates
title_full_unstemmed	Role of epidemiology in risk assessment: a case study of five ortho-phthalates
title_sort	role of epidemiology in risk assessment: a case study of five ortho-phthalates
publisher	BMC
publishDate	2021
url	https://doaj.org/article/09fff206d0574e8182513e32fe14854d
work_keys_str_mv	AT maricelvmaffini roleofepidemiologyinriskassessmentacasestudyoffiveorthophthalates AT birgitgeueke roleofepidemiologyinriskassessmentacasestudyoffiveorthophthalates AT kseniagroh roleofepidemiologyinriskassessmentacasestudyoffiveorthophthalates AT bethaniecarneyalmroth roleofepidemiologyinriskassessmentacasestudyoffiveorthophthalates AT janemuncke roleofepidemiologyinriskassessmentacasestudyoffiveorthophthalates
_version_	1718418925873528832

Role of epidemiology in risk assessment: a case study of five ortho-phthalates

Ejemplares similares